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This prospective, multi-center, single treatment clinical trial evaluates the clinical outcomes associated with non-invasive treatment to obtain lift and tightening of facial tissue and improve jawline definition in subjects with darker skin color utilizing the Ulthera® System to deliver focused ultrasound energy below the skin surface.
The primary objective of this clinical trial is to demonstrate the effectiveness of the Ulthera® System for the non-invasive treatment to obtain overall lift and tightening of facial tissue and jawline definition improvement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ulthera® System treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ulthera® System treatment | Device | Ulthera® System treatment delivering focused ultrasound energy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Overall Lifting and Tightening of Treated Tissue | The percentage of participants assessed to have improvement in skin laxity, i.e., lifted and tightened skin in the areas treated with the Ulthera System, as determined by three masked assessors comparing pre-treatment and 90-days post-treatment photos | 90 days post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Global Aesthetic Improvement at 90 Days Post-treatment | At 90 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. PGAIS = Physician Global Aesthetic Improvement Scale; SGAIS = Subject Global Aesthetic Improvement Scale. | 90 Days post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Assessment of Pain | Subject assessment of pain using a validated Numeric Rating Scale (NRS), 0-10, where 0 = no pain and 10=worse pain possible. Subjects' sensory responses to the treatment exposures were recorded using the NRS for each anatomical region. | During Ulthera treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hema Sundaram, M.D. | Dermatology, Cosmetic & Laser Surgery | Principal Investigator |
| Monte O Harris, M.D. | Harris Aesthetics, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harris Aesthetics, LLC | Chevy Chase | Maryland | 20815 | United States | ||
| Dermatology, Cosmetic & Laser Surgery |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26313402 | Derived | Harris MO, Sundaram HA. Safety of Microfocused Ultrasound With Visualization in Patients With Fitzpatrick Skin Phototypes III to VI. JAMA Facial Plast Surg. 2015 Sep-Oct;17(5):355-7. doi: 10.1001/jamafacial.2015.0990. |
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Fifty-four subjects who met study eligibility requirements were assigned a study subject ID. Two subjects withdrew from the study due prior to study treatment. Data from these subjects are not included in the demographic summaries or in the efficacy analyses. Fifty-two subjects received study treatment.
Subjects desiring lift/tightening of cheek tissue, or improved jawline definition and/or submental skin laxity, and were Fitzpatrick skin types 3-6 were recruited. Fifty-four subjects were enrolled at two facilities. Study recruitment initiated 2/16/11; follow-up concluded 1/18/12.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treated Subjects | All treated study subjects received a full face Ulthera® treatment. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Fifty-four subjects were consented and enrolled. Two subjects withdrew consent prior to treatment. Data analyses are based on 52 treated subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treated Subjects | Study subjects who received a full face Ulthera treatment. (n=52) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Overall Lifting and Tightening of Treated Tissue | The percentage of participants assessed to have improvement in skin laxity, i.e., lifted and tightened skin in the areas treated with the Ulthera System, as determined by three masked assessors comparing pre-treatment and 90-days post-treatment photos | Masked, qualitative assessment of standardized photographs at 90 days post treatment compared to baseline, could not be completed as images taken at one site were not recovered due to poor data management and staffing issues at the site. | Posted | 90 days post treatment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enrolled Subjects | Includes all subjects enrolled, including 52 treated subjects and 2 non-treated subjects who withdrew consent prior to treatment. |
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Study Limitations:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Disclosure Manager | Merz Pharmaceuticals | clinicaltrials@merz.com |
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| Global Aesthetic Improvement at 180 Days Post-treatment | At 180 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. PGAIS = Physician Global Aesthetic Improvement Scale; SGAIS = Subject Global Aesthetic Improvement Scale. | 180 days post-treatment |
| Patient Satisfaction Questionnaire | Subjects indicated whether they saw improvement, i.e., providing a Yes/No response, in face and neck characteristics at three months (D90) post Ulthera treatment. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment. Subjects' Yes/No responses were tabulated. | 90 Days post-treatment |
| Patient Satisfaction Questionnaire | Subjects indicated whether they saw improvement, i.e., providing a Yes/No response, in face and neck characteristics at six months (D180) post Ulthera treatment. Pre-treatment and Day 180 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment. Subjects' Yes/No responses were tabulated. | 180 days post-treatment |
| Rockville |
| Maryland |
| 20852 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
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| Fitzpatrick Skin Type | Skin Type I = White;very fair,red or blonde hair blue eyes;freckles;Always burns, never tans Skin Type II = White, fair, red or blond hair; blue, hazel or green eyes;Usually burns, tans with difficulty Skin Type III = Cream white; fair with any eye or hair color (common); Sometimes mild burn, gradually tans Skin Type IV = Brown; typical Mediterranean Caucasian skin; Rarely burns, tans with ease Skin Type V = Dark Brown; mid-eastern skin types; Very rarely burns, tans easily Skin Type VI = Black; Never burns, tans very easily | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
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| Secondary | Global Aesthetic Improvement at 90 Days Post-treatment | At 90 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. PGAIS = Physician Global Aesthetic Improvement Scale; SGAIS = Subject Global Aesthetic Improvement Scale. | The GAIS is 5-point scale (1-5) describing an overall assessment as follows:
| Posted | Number | percentage of participants improved | 90 Days post-treatment |
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| Secondary | Global Aesthetic Improvement at 180 Days Post-treatment | At 180 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. PGAIS = Physician Global Aesthetic Improvement Scale; SGAIS = Subject Global Aesthetic Improvement Scale. | Subjects completing the 180-Day SGAIS = 39; however, the 180-Day PGAIS was not obtained for 2 subjects. PGAIS data are based on n=37. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:
| Posted | Number | percentage of participants improved | 180 days post-treatment |
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| Secondary | Patient Satisfaction Questionnaire | Subjects indicated whether they saw improvement, i.e., providing a Yes/No response, in face and neck characteristics at three months (D90) post Ulthera treatment. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment. Subjects' Yes/No responses were tabulated. | Data analyzed includes PSQ responses at 90 days post-treatment assessing subjects' satisfaction with study treatment. Responses were tabulated. Outcomes reported represent the percentage of subjects reporting any satisfaction, i.e., Very Satisfied and Satisfied. | Posted | Number | percentage of participants Satisfied | 90 Days post-treatment |
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| Secondary | Patient Satisfaction Questionnaire | Subjects indicated whether they saw improvement, i.e., providing a Yes/No response, in face and neck characteristics at six months (D180) post Ulthera treatment. Pre-treatment and Day 180 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment. Subjects' Yes/No responses were tabulated. | Data analyzed includes PSQ responses at 180 days post-treatment assessing subjects' satisfaction with study treatment. Responses were tabulated. Outcomes reported represent the percentage of subjects reporting any satisfaction, i.e., Very Satisfied and Satisfied. | Posted | Number | percentage of participants Satisfied | 180 days post-treatment |
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| Other Pre-specified | Subject Assessment of Pain | Subject assessment of pain using a validated Numeric Rating Scale (NRS), 0-10, where 0 = no pain and 10=worse pain possible. Subjects' sensory responses to the treatment exposures were recorded using the NRS for each anatomical region. | Posted | Mean | Full Range | Average NRS score | During Ulthera treatment |
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| 54 |
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| Title | Measurements |
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